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Remodeling a cardiac annulus

a heart valve and annulus technology, applied in the field of medical devices and methods, can solve the problems that neither the terms used to describe a particular subset of surgical or other procedures should be interpreted as restricting, and achieve the effect of constricting the heart valve annulus and preserving the mobility of the valve leaflets

Inactive Publication Date: 2006-06-15
ANCORA HEART INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0011] The methods described herein generally provide methods for enhanced treatment of a cardiac valve annulus such as a mitral valve annulus. Methods generally involve securing a plurality of anchors to the valve annulus, constricting the valve annulus by cinching a tether connecting the plurality of anchors, and allowing ingrowth of tissue around and / or into the cinched assembly of tether and anchors. The annulus may be constricted to correct the position of the valve leaflets. Thus, constriction of the annulus may be any reduction or change in shape of the annulus to correct the function of the leaflets (e.g., allowing the leaflets to open and close properly). The cinched assembly typically comprises the plurality of anchors and at least one tether connecting the plurality of anchors. This assembly may be adjusted while visualizing at least a part of the assembly, to help adjust the position and mobility of the valve leaflets as the annulus is cinched. After the annulus is secured into the desired shape or position, the assembly typically maintains this corrected shape or position until the formation of new fibrous tissue which holds the shape of the annulus. Thus, the anchor and tether assembly encourages remodeling of the annulus by supporting the annulus in the corrected shape until the formation of new tissue. In some variations, the assembly is configured to encourage growth of new tissue (including fibrous scar tissue) around the assembly and / or into the assembly.
[0019] Also described herein are method of remodeling a valve annulus while preserving mobility of the valve leaflets. The method typically includes the steps of securing a plurality of anchors to at least a portion of the valve annulus, constricting the valve annulus by cinching a tether connecting the plurality of anchors (wherein the plurality of anchors and the tether are configured as a cinchable assembly), and monitoring the mobility of the heart valve leaflets in real time while constricting the heart valve annulus. As described above, the annulus may be secured so that it remains in position (or shape) at least long enough to allow the formation of fibrous scar tissue at least partially around the annulus.

Problems solved by technology

Furthermore, although the terms “less invasive” and “minimally invasive” may sometimes be used interchangeably in this application, neither of these nor terms used to describe a particular subset of surgical or other procedures should be interpreted as limiting.

Method used

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  • Remodeling a cardiac annulus

Examples

Experimental program
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example 1

[0115]FIGS. 20A to 20D illustrate a schematic example of a non-percutaneous insertion of a plurality of anchors that are inserted one at a time by deploying individual anchors from the end of a deployment device. The mitral valve annulus may be exposed by incising the left atrium. A first anchor may be aligned on the deployment device using a loading tool which orients the legs of the anchor (e.g., parallel to the shaft of the deployment device), so that the tips of the anchor's legs can be flush with the tip of the device. The tether can then be threaded through a slot in delivery device so that it passes through an eyelet of the anchor. The tip of the delivery device can then be positioned under a leaflet near the posterior commiusure 2001 as shown in FIG. 20A. The end of the deployment device (from which the anchor will be released) is pointed radially outward so that the tip contacts the ventricular wall, just below the annulus. In one variation, the anchor is deployed by squeez...

example 2

[0121] As described above, surgical annuloplasty typically constricts the diameter of the valve by suturing an ring (having a diameter that is smaller than the dysfunctional diameter of the annulus) directly to the annular tissue. Other methods of constricting the annuls involve placing devices in regions of the heart (e.g., the CS that are located in compliant fatty tissue outside of the atrium) that are remote from the annulus. Such methods may limit the effectiveness of the annuloplasty, the ability to constrict the annulus, and particularly the ability to constrict and retain the annulus for extended periods of time while not substantially limiting the range of motion of the valve leaflets

[0122]FIG. 22 graphically summarizes the results of the subvalvular approach described herein. Sheep were operated on as described, so that a cinchable assembly (e.g., anchors and a tether) was implanted and cinched to constrict the mitral valve orifice. As can be seen from the table in FIG. 2...

example 3

[0125] Animals in which the cinchable assemblies had been chronically implanted (e.g., 1-6 months) were examined to determine the response of the annular tissue to the implant. All of the excised hearts showed extensive fibrous tissue coverage of the implant, as well as ingrowth by fibrous tissue. For example, FIG. 25 shows a dissected mitral valve annulus containing a heart having a implant which was present for approximately three months. As can be seen, assembly has been encapsulated in scar tissue 2501 (fibrous tissue). This fibrous tissue is resilient (e.g., strong) and resists expansion, even after cutting the tether of the assembly.

[0126] This encapsulation may also be seen in cross-sections through the tissue, as seen in FIG. 26A-26B. FIG. 26 also illustrates the infiltration of fibrous tissue into the implants. Infiltration of fibrous tissue into the cinchable assembly can result the formation of a new annular band. FIG. 27 also illustrates cross-sections from a heart in w...

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Abstract

Described herein are methods of remodeling the base of a ventricle. In particular, methods of remodeling a valve annulus by forming a new fibrous annulus are described. These methods may result in a remodeled annulus that corrects valve leaflet function without substantially inhibiting the mobility of the leaflet. The methods of remodeling the base of the ventricle include the steps of securing a plurality of anchors to the valve annulus beneath one or more leaflets of the valve, constricting the valve annulus by cinching a tether connecting the anchors, and securing the anchors in the cinched conformation to allow the growth of fibrous tissue. The annulus may be cinched (e.g., while visualizing the annulus) so that the mobility of the valve leaflets is not significantly restricted. The remodeled annulus is typically constricted to shorten the diameter of the annulus to correct for valve dysfunction (e.g., regurgitation).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10 / 792,681, filed Mar. 2, 2004, which claims the benefit of U.S. provisional patent application Ser. No. 60 / 459,735, filed on Apr. 1, 2003, U.S. provisional patent application Ser. No. 60 / 462,502, filed on Apr. 10, 2003, and U.S. provisional patent application Ser. No. 60 / 524,922, filed on Nov. 24, 2003, and which is a continuation-in-part of U.S. patent application Ser. No. 10 / 741,130, filed on Dec. 19, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10 / 656,797, filed on Sep. 4, 2003, and is a continuation-in-part of U.S. patent application Ser. No. 10 / 461,043, filed on Jun. 13, 2003, the latter of which claims the benefit of U.S. provisional patent application Ser. No. 60 / 388,935, filed on Jun. 13, 2002, U.S. patent application Ser. No. 60 / 429,288, filed on Nov. 25, 2002, U.S. provisional patent application Ser. No. 60 / 445,890, fil...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61B17/04A61B17/00A61B17/06A61B17/064A61B17/068A61B17/10A61B17/12
CPCA61B17/00234A61B17/0401A61B17/064A61B17/0682A61B2017/00243A61B2017/00783A61B2017/00867A61B2017/0409A61B2017/0414A61B2017/0443A61F2/2445
Inventor STARKSEN, NIEL F.TO, JOHNMORALES, RODOLFO A.
Owner ANCORA HEART INC
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